Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression Episode

Phase 3

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: Placebo; Drug: Aripiprazole

• Registration Number: NCT00080314
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

The purpose of this study is to evaluate flexible doses (5-30mg) of aripiprazole versus placebo in patients with bipolar depression.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2004-03-26
• Study First Submitted QC: 2004-03-29
• Study First Posted: 2004-03-30
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2008-06
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A2	Placebo	-
A1	Aripiprazole	-

Primary Outcome Measures

Name	Time	Method
Change on a depression rating scale at endpoint

Secondary Outcome Measures

Name	Time	Method
Response rate and Clinical Global Impression scale at endpoint

Trial Locations

Locations (2)

Local Institution; 🇺🇸 Bellevue, Washington, United States

Local Insstitution; 🇺🇸 Honolulu, Hawaii, United States